Galera Appoints Mark J. Bachleda as Chief Commercial Officer and Jennifer Evans Stacey as Chief Legal and Compliance Officer

Rhea-AI Summary

Galera Therapeutics, Inc. (Nasdaq: GRTX) has announced the appointments of Mark J. Bachleda as Chief Commercial Officer and Jennifer Evans Stacey as Chief Legal and Compliance Officer. Both executives bring over 25 years of experience in the biopharmaceutical industry. Bachleda, previously with Bristol Myers Squibb, will focus on the commercialization of avasopasem, a treatment for severe oral mucositis in cancer patients. Stacey, formerly at The Wistar Institute, will lead legal and compliance efforts. These hires come as Galera aims to transition into a commercial-stage company.

Positive

• Appointment of experienced executives strengthens leadership.
• Bachleda's experience in CAR T therapy commercialization is valuable for avasopasem.
• Stacey's background in compliance and legal affairs enhances corporate governance.

Negative

• Concerns regarding continuity and gaps in experience in new roles.

MALVERN, Pa., Oct. 12, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced the appointment of Mark J. Bachleda, Pharm.D., M.B.A., as Chief Commercial Officer (CCO) and Jennifer Evans Stacey, Esq., as Chief Legal and Compliance Officer (CLCO) and Secretary. Both executives join Galera with over 25 years of leadership experience within the biopharmaceutical industry.

“We are thrilled to welcome Mark and Jennifer to Galera at this critical point in the Company’s growth,” said Mel Sorensen, M.D., Galera’s President and CEO. “As we begin to expand our focus toward becoming a commercial-stage company, we will leverage our two new colleagues’ executive-level experiences to continue shaping Galera’s corporate and regulatory strategy. We look forward to their invaluable contributions that will help position us to achieve our mission of delivering novel therapies that improve outcomes for patients with cancer undergoing radiotherapy.”

Prior to joining Galera, Mark served as Vice President & U.S. Business Unit Head for Bristol Myers Squibb’s (BMS) CAR T cell therapy franchise. At BMS, he was responsible for building core U.S. commercial capabilities and the successful launch execution of Breyanzi^® and Abecma^®. Prior to BMS, Mark was Vice President of Sales at Juno Therapeutics, a biotechnology company acquired by Celgene in 2018. Prior to Juno, Mark worked at Amgen for 15 years in a variety of U.S. and international commercial operations roles. His most recent role was General Manager of Amgen Czech Republic, where he led an enterprise of 11 commercialized therapies including launches of Kyprolis^®, Blincyto^®, and Repatha^®. Mark is a registered pharmacist and received his Pharm.D. degree from the University of Illinois at Chicago. He completed a post-doctoral fellowship in health policy and economics at Thomas Jefferson University and earned M.B.A. degrees from both Columbia University and the University of California, Berkeley.

“I am delighted to join Galera as the Company prepares for potential commercialization of its lead asset, avasopasem,” commented Mark J. Bachleda, Pharm.D., M.B.A. “In only a few years, the Company has advanced avasopasem into a pivotal Phase 3 trial, which has the potential to become the new standard of care for severe oral mucositis in patients with head and neck cancer. I am eager to collaborate with the Galera management team as we dedicate our efforts to bringing this therapy to market and making it available for cancer patients in need.”

Previously, Jennifer served as Vice President, General Counsel, Secretary and Government Relations at The Wistar Institute, an independent international biomedical research institution. During her tenure, she drafted and negotiated license and equity agreements to launch six start-ups that helped advance Wistar technology. Prior to her role at Wistar, Jennifer was the Senior Vice President, General Counsel, Human Resources and Secretary for Antares Pharma, a publicly traded pharmaceuticals company. Before that, Jennifer was Executive Vice President, General Counsel, Human Resources and Secretary for Auxilium Pharmaceuticals, Inc., a publicly traded biopharmaceutical company acquired by Endo International plc. Jennifer earned her J.D. from the University of Pennsylvania Law School and her A.B. from Princeton University.

“I am excited to partner with Galera’s driven and dynamic management team to help advance the Company’s novel dismutase mimetic product candidates through late-stage development,” said Jennifer Evans Stacey, Esq. “Galera’s assets have the potential to significantly improve quality of life for patients. I look forward to leading the Company’s legal, compliance and human resources divisions during this significant time.”

About Galera Therapeutics
Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s lead product candidate is avasopasem manganese (avasopasem, or GC4419), a selective small molecule dismutase mimetic in late-stage development to reduce the incidence and severity of radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer. Avasopasem is also in development for radiotherapy-induced esophagitis in patients with lung cancer. Avasopasem has been granted FDA Fast Track and Breakthrough Therapy designations for the reduction of SOM induced by radiotherapy, with or without systemic therapy. Galera’s second dismutase mimetic product candidate, GC4711, is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding: expectations surrounding our growth and the continued advancement of our product pipeline; the potential, safety, efficacy, and regulatory and clinical development of Galera’s product candidates; plans for the commercial launch of avasopasem; and expected contributions from the newly hired executives. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause Galera’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Galera’s limited operating history; anticipating continued losses for the foreseeable future; needing substantial funding and the ability to raise capital; Galera’s dependence on avasopasem manganese (GC4419); uncertainties inherent in the conduct of clinical trials; difficulties or delays enrolling patients in clinical trials; the FDA’s acceptance of data from clinical trials outside the United States; undesirable side effects from Galera’s product candidates; risks relating to the regulatory approval process; failure to capitalize on more profitable product candidates or indications; ability to receive or maintain Breakthrough Therapy Designation or Fast Track Designation for product candidates; failure to obtain regulatory approval of product candidates in the United States or other jurisdictions; ongoing regulatory obligations and continued regulatory review; risks related to commercialization; risks related to competition; ability to retain key employees and manage growth; risks related to intellectual property; inability to maintain collaborations or the failure of these collaborations; Galera’s reliance on third parties; the possibility of system failures or security breaches; liability related to the privacy of health information obtained from clinical trials and product liability lawsuits; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; environmental, health and safety laws and regulations; the impact of the COVID-19 pandemic on Galera’s business and operations, including preclinical studies and clinical trials, and general economic conditions; risks related to ownership of Galera’s common stock; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption “Risk Factors” in Galera’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and Galera’s other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statements speak only as of the date of this press release and are based on information available to Galera as of the date of this release, and Galera assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contacts:
Christopher Degnan
Galera Therapeutics, Inc.
610-725-1500
cdegnan@galeratx.com

William Windham
Solebury Trout
646-378-2946
wwindham@soleburytrout.com

Media Contact:
Zara Lockshin
Solebury Trout
646-378-2960
zlockshin@soleburytrout.com

 

FAQ

Who are the new executives appointed at Galera Therapeutics?

Mark J. Bachleda is the new Chief Commercial Officer, and Jennifer Evans Stacey is the new Chief Legal and Compliance Officer at Galera Therapeutics.

What is the significance of the new appointments at Galera?

The appointments are expected to enhance Galera's transition to a commercial-stage company, focusing on the launch of its lead product, avasopasem.

What is avasopasem, and why is it important for Galera?

Avasopasem is a treatment aimed at reducing severe oral mucositis in head and neck cancer patients, with potential commercialization on the horizon.

What experience does Mark J. Bachleda bring to Galera Therapeutics?

Bachleda has extensive experience in commercial operations and was previously responsible for successful product launches at Bristol Myers Squibb.

What role will Jennifer Evans Stacey play at Galera Therapeutics?

She will lead the legal, compliance, and human resources divisions, helping to navigate regulatory challenges as the company develops its product candidates.